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510(k) Data Aggregation

K Number

K140558

Device Name

PROCTIGARD

Manufacturer

ACCESS PHARMACEUTICALS, INC

Date Cleared

2014-07-16

(133 days)

Product Code

PHN

Regulation Number

N/A

Intended Use

ProctiGard™ is indicated for the symptomatic management of rectal mucositis.

Device Description

ProctiGard™ is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the symptomatic management of rectal mucositis. When gently applied via the enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.

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K Number

K062795

Device Name

MUGARD MUCOADHESIVE ORAL WOUND RINSE

Manufacturer

ACCESS PHARMACEUTICALS, INC

Date Cleared

2006-12-11

(84 days)

Product Code

OLR, MGQ

Regulation Number

N/A

Intended Use

MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.

Device Description

MuGard™ Mucoadhesive Oral Wound Rinse is a viscous liquid supplied in plastic bottles and is designed for the management of oral mucositis/stomatitis and other oral wounds. When swirled gently round the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa.

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